Recruiting
Phase 1

FLD-103

Sponsor:

Feldan Therapeutics

Code:

NCT07670858

Conditions

Nodular Basal Cell Carcinoma

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Intralesional FLD-103

Study Details

Brief summary:

The goal of this clinical trial is to determine safety, tolerability, pharmacokinetics, preliminary efficacy, and Maximum Tolerable Dose (MTD), of intralesional FLD-103 when administered to subjects with Basal Cell Carcinoma (BCC). The main questions it aims to answer are:

  • Is FLD-103 safe and well tolerated?
  • What is a safe dose of FLD-103 for future studies?
  • How much FLD-103 enters the bloodstream and how long does it take to be cleared from the body?
  • Does FLD-103 reduce the size of the tumor?

Participants will:

  • Receive either a Single Ascending Dose (SAD) of FLD-103 or Multiple Ascending Doses (MAD) of FLD-103 once weekly for four (4) weeks.
  • Visit the clinic a day after receiving a dose and once weekly for four (4) weeks after that for checkups and tests.

Conditions

Nodular Basal Cell Carcinoma

Study ID

NCT07670858

Start date

Oct 30, 2024

Status verified date

Jun, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Feb, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • You are between 18 and 85 years old.
  • You are willing to attend all study visits and follow the study procedures.
  • You have been diagnosed with at least one nodular basal cell carcinoma (a type of skin cancer) that has never been treated and suitable for treatment and final excision by the Investigator.
  • You are willing to avoid certain medications during the study as instructed by the study doctor.
  • You are not currently participating in another clinical study.
  • If you are a woman who could become pregnant, you must:
  • Have a negative pregnancy test at the start of the study.
  • Use effective birth control during the study and for 90 days after your last dose.
  • Not breastfeed during the study and for 90 days after your last dose.
  • If you are a man, you must use a condom during the study and for 90 days after your last dose if you have sex with a partner who could become pregnant.

Exclusion Criteria:

  • You are currently breastfeeding.
  • You have a known allergy or sensitivity to any ingredient in the study drug or to red tattoo ink.
  • Your skin lesion is located in a high-risk area, such as near the eyes, nose, ears, lips, scalp, or on the hands or fingers.
  • Your skin lesion needs to be removed urgently.
  • Your basal cell carcinoma has spread to other parts of the body.
  • You have received radiation therapy directly on or near the skin lesion being treated in this study.
  • You have received phototherapy (such as Ultraviolet A or B light therapy) in the past 4 weeks or are expected to receive it during the study.
  • You have been diagnosed with a liver or kidney disease that the study doctor considers significant.
  • You are immunocompromised or have an active infection such as Human Immunodeficiency Virus (HIV), Hepatitis B, Hepatitis C or active Tuberculosis.
  • You have or had another cancer in the past 5 years
  • You have a skin condition associated with an increased risk of developing skin cancers (such as Xeroderma Pigmentosum).
  • You have uncontrolled high blood pressure or a heart rhythm problem.
  • You have had significant alcohol or drug use issues in the past 6 months, or have a mental health condition that the study doctor believes may affect your ability to participate safely.
  • You are currently taking certain medications that are not allowed during the study
  • You are an employee or family member of an employee at the study site or of the study doctor.

Study Design

Enrollment

48 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: SAD Dose 1

A single dose of FLD-103 0.5 mg/mL (lesion size-determined volume)

experimental: SAD Dose 2

A single dose of FLD-103 1 mg/mL (lesion size-determined volume)

experimental: SAD Dose 3

A single dose of FLD-103 3 mg/mL (lesion size-determined volume)

experimental: SAD Dose 4

A single dose of FLD-103 5 mg/mL (lesion size-determined volume)

experimental: MAD Dose 1

A multiple doses of FLD-103 0.5 mg/mL once weekly for four (4) weeks (lesion size-determined volume).

experimental: MAD Dose 2

A multiple doses of FLD-103 1 mg/mL once weekly for four (4) weeks (lesion size-determined volume).

experimental: MAD Dose 3

A multiple doses of FLD-103 3 mg/mL once weekly for four (4) weeks (lesion size-determined volume).

experimental: MAD Dose 4

A multiple doses of FLD-103 5 mg/mL once weekly for four (4) weeks (lesion size-determined volume).

experimental: MAD-FV Dose 2

A multiple doses of FLD-103 1 mg/mL once weekly for four (4) weeks with a fixed volume (FV).

experimental: MAD-FV Dose 3

A multiple doses of FLD-103 3 mg/mL once weekly for four (4) weeks with a fixed volume (FV).

experimental: MAD-FV Dose 4

A multiple doses of FLD-103 5 mg/mL once weekly for four (4) weeks with a fixed volume (FV).

Interventions

Intralesional FLD-103

Intralesional and perilesional injection of FLD-103

Primary outcome measure

  • Frequency, severity and relationship of Treatment Emergent Adverse events (TEAEs) [ Time Frame: From enrollment until the end-of-study (EOS) visit (up to Day 36 for SAD / up to Day 57 for MAD/MAD-FV) ]
  • Local Skin Response (LSR) and other potential localised responses [ Time Frame: From enrollment until the end-of-study (EOS) visit (up to Day 36 for SAD / up to Day 57 for MAD/MAD-FV) ]

Central Contacts and Locations

Central contacts

Catherine Lippé

1 581-397-8597clippe@feldan.com

Locations

Equity Medical

Recruiting

Bowling Green, Kentucky, United States, 42104

More Information

Sponsor

Feldan Therapeutics

Last update posted

Jun 29, 2026

Last verified

Jun, 2026

Keywords

  • nBCC
  • Intralesional

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Feldan Therapeutics on 2026-06-29.